PEG-rhG-CSF in Elderly Patients With Small Cell Lung Cancer Receiving Chemotherapy
2018年12月16日 更新者：CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Multi-center, Open, One-arm Clinical Study Evaluating the Efficacy and Safety of Jinyouli (PEGylated Recombinant Human Granulocyte Stimulating Factor, PEG-rhG-CSF) in Preventing Neutropenia After Chemotherapy in Elderly Patients With Small Cell Lung Cancer
Evaluation of the efficacy and safety of Jinyouli in preventing neutropenia in multiple chemotherapy cycles in elderly patients with small cell lung cancer through a multicenter, open, one-arm study Subjects with newly diagnosed small cell lung cancer who met the inclusion/exclusion criteria, chemotherapy regimen: etoposide: 100 mg/m2, d1-3, carboplatin: AUC=5, d1, q21d, prophylactic use test 48 h after chemotherapy Drug PEG-rhG-CSF.
調査の概要
研究の種類
介入
入学 (予想される)
61
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Beijing
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Beijing、Beijing、中国、100142
- 募集
- Bejing Cancer Hospital
-
コンタクト：
- Jun Zhao, PhD
- 電話番号：86-010-88196456
- メール：ohjerry@163.com
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
70年歳以上 (高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Age ≥ 70 years old, gender is not limited;
- Small cell lung cancer patients diagnosed by histopathology or cytology;
- ECOG = 0-1;
- The estimated survival period is more than 3 months;
- No obvious signs of hematological disease, defined as Hb≥90g/dL, WBC≥4.0×10^9/L, ANC≥2×10^9/L, PLT≥100×10^9/L before enrollment. And no bleeding tendency;
- No obvious abnormalities were observed in the electrocardiogram examination;
- Liver function tests ALT, AST, TBIL indicators are within 2.5 times the upper limit of normal values. If due to liver metastasis, the above indicators should be within 5 times of the upper limit of normal. If LDH is elevated due to non-tumor causes, LDH should be ≤ 2.5 times the upper limit of normal; if LDH is elevated due to tumor, it can be enrolled;
- Renal function test BUN, UA within 1.5 times the upper limit of normal value, creatinine clearance rate> 60ml / min;
- Subjects (or their legal representatives/guardians) must sign an informed consent form indicating that they understand the purpose of the study, understand the necessary procedures for the study, and are willing to participate in the study.
Exclusion Criteria:
- There are currently uncontrollable infections, body temperature ≥ 38.0 ° C;
- Patients with previous malignant tumors that have not been cured or have bone marrow metastasis;
- Patients with prophylactic antibiotics;
- Accepting other test drugs at the same time or participating in other clinical trials;
- Those who are allergic to this product or other genetically engineered E. coli-derived biological products;
- The patient has any myelodysplastic and other blood system diseases;
- Patients who have received hematopoietic stem cell transplantation or organ transplantation;
- The patient has a severe mental or neurological condition that affects informed consent and/or adverse reaction presentation or observation.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：PEG-rhG-CSF
Jin Youli(PEG-rhG-CSF): The dose is determined according to the patient's weight. Those who weighed more than ≥45kg were given 6mg/time, and those who were <45kg or less were given 3mg/time. Administration method: Subcutaneous injection, the lower edge of the deltoid muscle of both arms is preferentially selected, and each injection is injected once every chemotherapy cycle. Dosing time: 48 h after chemotherapy. |
Subjects with newly diagnosed small cell lung cancer who met the inclusion/exclusion criteria were prophylactically administered the test drug PEG-rhG-CSF 48 h after chemotherapy. Jin Youli（PEG-rhG-CSF）: The dose is determined according to the patient's weight. Those who weighed more than ≥45kg were given 6mg/time, and those who were <45kg or less were given 3mg/time. Administration method: Subcutaneous injection, the lower edge of the deltoid muscle of both arms is preferentially selected, and each injection is injected once every chemotherapy cycle. Dosing time: 48 h after chemotherapy. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The incidence of grade III/IV neutropenia in the first cycle of PEG-rhG-CSF.
時間枠：through first cycle of PEG-rhG-CSF,an average of 1 month
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The incidence of grade III/IV neutropenia in the first cycle of PEG-rhG-CSF.
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through first cycle of PEG-rhG-CSF,an average of 1 month
|
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The incidence of grade III/IV neutropenia in the second cycle of PEG-rhG-CSF.
時間枠：through second cycle of PEG-rhG-CSF,an average of 1 month
|
The incidence of grade III/IV neutropenia in the second cycle of PEG-rhG-CSF.
|
through second cycle of PEG-rhG-CSF,an average of 1 month
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The incidence of febrile neutropenia in cycles 1 and 2
時間枠：through 1-2 cycles of PEG-rhG-CSF,an average of 2 month
|
Febrile neutropenia (FN) is defined as oral temperature >38.3 ° C (underarm temperature >38.1 ° C) or continuous measurement of oral temperature >38 ° C (underarm temperature >37.8 ° C) in 2 h, and ANC <0.5×10^9/L, or expected to be <0.5×10^9/L
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through 1-2 cycles of PEG-rhG-CSF,an average of 2 month
|
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The ANC recovery time in cycles 1 and 2
時間枠：through 1-2 cycles of PEG-rhG-CSF,an average of 2 month
|
Defined as the patients who appear ANC<2.0×10^9/L，from the first day of chemotherapy, to the time of ANC≥ 2.0×10^9/L, take the median.
|
through 1-2 cycles of PEG-rhG-CSF,an average of 2 month
|
|
The incidence of infection
時間枠：up to 30 days after the patient study completion
|
up to 30 days after the patient study completion
|
|
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The incidence of antibiotic use
時間枠：up to 30 days after the patient study completion
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up to 30 days after the patient study completion
|
|
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Incidence of chemotherapy dose adjustment due to neutropenia
時間枠：through the study completion,an average of 3 months
|
through the study completion,an average of 3 months
|
|
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Chemotherapy delay time
時間枠：through the study completion,an average of 3 months
|
through the study completion,an average of 3 months
|
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Incidence of chemotherapy delay caused by neutropenia
時間枠：through the study completion,an average of 3 months
|
through the study completion,an average of 3 months
|
|
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The duration of febrile neutropenia in cycles 1 and 2
時間枠：through 1-2 cycles of PEG-rhG-CSF,an average of 2 month
|
through 1-2 cycles of PEG-rhG-CSF,an average of 2 month
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence and severity of adverse events
時間枠：through the study completion,an average of 3 months
|
All adverse events will be recorded from the time of signing the informed consent form to 30 days after the last dose.
Adverse events 30 days after the last dose, only those adverse events associated with the study drug were recorded.
|
through the study completion,an average of 3 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年12月5日
一次修了 (予想される)
2019年12月1日
研究の完了 (予想される)
2020年2月1日
試験登録日
最初に提出
2018年12月10日
QC基準を満たした最初の提出物
2018年12月12日
最初の投稿 (実際)
2018年12月17日
学習記録の更新
投稿された最後の更新 (実際)
2018年12月19日
QC基準を満たした最後の更新が送信されました
2018年12月16日
最終確認日
2018年12月1日
詳しくは
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